Bodily fluid testing systems can be used to detect various analyte concentrations within a bodily fluid sample to provide accurate and detailed medical information. Such information can be used to aid in the diagnosis and/or treatment of certain medical conditions such as diabetes. For example, in diabetic monitoring applications, analyzers can be used by diabetic patients or physicians to detect high (i.e., hyperglycemia) or low (i.e., hypoglycemia) blood glucose levels. The monitored levels can aid in the treatment and management of diabetes by notifying a user of abnormal levels, which allows the user to make necessary adjustments such as increasing sugar or insulin intake to stabilize blood glucose levels. As another example, HbA1c, which is also referred to as glycated hemoglobin, is an analyte used for both monitoring and screening of diabetes, as it captures the average plasma glucose concentration over prolonged periods. Other examples are analytes that are more general to other chronic conditions. Such examples include lipids (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides), serum creatinine, hemoglobin and ketones, which can be measured in various bodily fluids, such as blood, urine and saliva. Currently, there are several systems and methods used in medical diagnostic monitoring and screening.
One conventional approach includes the use of a stand-alone test system to process and analyze data related to analyte concentrations within a measured sample of a fluid based on a reflectance reading from a reagent test strip. For example, in U.S. Pat. No. 5,304,468 to Phillips et al., a method is disclosed for taking a reflectance reading from a reagent pad that consists of a porous matrix. The reflectance reading is based upon a reflectance change resulting from penetration of the porous matrix by an aqueous solution. Another method is disclosed in U.S. Pat. No. 6,574,425 to Weiss et al., which uses an “ultra-sensitive” meter (a “reflectometer”) to accurately resolve the full range of developed subtle color shade changes produced by the transdermal extraction of analytes.
Some other conventional approaches include the use of integrated systems comprising a blood glucose monitor and an external processing device for data management and analysis such as those disclosed in U.S. 2013/0276521 to Fuerst et. al, U.S. Pat. No. 7,935,307 to Angelides, and U.S. Published Application No. 20120142084 to Dunne et. al. Additionally, other integrated systems use naked mobile device connections, where, e.g., a rapid diagnostics test (RDT) is performed by generating a digital image of an RDT strip using a camera unit and software application running on a mobile device.
Drawbacks to such conventional approaches include the inability to accurately quantitatively analyze chemistries that have different reaction color spectra, to accommodate various test strip dimensions or to dynamically update system parameters according to various testing requirements. Thus, there is a need for an affordable and cost effective system that can perform an array of color analyses while being universal in design to accommodate various testing requirements.